Dose-escalation clinical trial to find the maximum tolerable dose after single oral dose of HL237
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002539
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 56
1) A healthy adult male aged 20 years or older and 45 years old at the time of the screening test
2) Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight
3) Proper contraception during the clinical trial period
4) After hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement
1) Clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease
2) a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
3) a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives
4) a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics-Cmax, AUClast, AUCinf, %AUCextra, tmax, t1/2, CL/F, Vd/F, fe, CLR
- Secondary Outcome Measures
Name Time Method Safety